Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

For Immediate Release

Statement

Increasingly, Americans are seeking healthy food options, whether they’re eating out or dining at home. Their ability to choose healthy foods starts with their ability to understand what’s in their food in the first place. Public surveys suggest that Americans want food makers to be transparent about what is in a product and how it’s made. The food industry has responded by innovating and reformulating their products. Among other things, they’re boosting fiber content, and curbing the amount of sodium and sugar.

At the same time, we at the U.S. Food and Drug Administration are doing our part to ensure consumers have updated, science-based information to help them make more informed dietary choices.

In March, I announced a comprehensive, multi-year Nutrition Innovation Strategy intended to drive additional actions that the FDA can take to reduce preventable death and disease related to poor nutrition. Part of this effort includes taking final steps on the new Nutrition Facts label.

This is our first overhaul of the food label in more than 20 years. It’s aimed at making sure that consumers have access to an updated label that’s based on updated science and provides more information to empower them to choose healthful diets. I also recognize that it’s crucial for the FDA to provide clear expectations so that industry can meet our new labeling requirements and that we provide the greatest flexibility possible, while still maintaining an approach that is grounded in rigorous science.

As part of those efforts, today the FDA issued decisions on citizen petitions regarding additional dietary fibers. We also issued a guidance that will allow food manufacturers to count these fibers when calculating the total amount of fiber per serving to declare on the Nutrition Facts label. They can also be counted as fiber on the Supplement Facts label. The eight new fibers are: mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber and apple fiber, among many others); arabinoxylan; alginate; inulin and inulin-type fructans; high amylose starch (resistant starch 2); galactooligosaccharide; polydextrose; and resistant maltodextrin/dextrin.

Our work is not done. We have received additional petitions asking for additional fibers to be recognized in a similar fashion to the eight dietary fibers we are identifying today. We are actively evaluating these additional requests, working through the petitions and, in some cases, supplementary information provided by the petitioners, in an efficient manner. We recognize the importance of providing timely responses so that food makers have certainty around their manufacturing decisions. We also welcome the submission of additional petitions in the future as science emerges and as new ingredients are identified. Our expectation is that we will continue to evaluate additional dietary fibers on a rolling basis, and we expect that additional fibers may be recognized in the future.

All of these decisions build off of the FDA’s evidence-based definition of dietary fiber published in 2016, which stated that dietary fiber declared on the updated Nutrition Facts label can include certain naturally-occurring fibers that are “intrinsic and intact” in plants as well as seven other added isolated or synthetic fibers that are well recognized by the scientific community for having physiological benefits. Before the FDA established this definition, manufacturers could declare synthetic or isolated fibers as fiber on the label without evidence that these fibers had beneficial physiological effects on the body. Consumers can be assured that non-digestible carbohydrates counted as fiber on the new Nutrition Facts label have health benefits grounded in scientific evidence. Eating foods rich in dietary fiber, as recommended by the Dietary Guidelines for Americans, can help cholesterol levels, increase feelings of fullness (satiety) resulting in reduced calorie intake, and increase the frequency of bowel movements.

We are taking a flexible approach to dietary fiber, allowing for the possibility of additional fibers to be added to the list of those meeting our dietary fiber definition if the scientific evidence shows they are physiologically beneficial. In addition to other relevant scientific literature, we carefully reviewed submitted petitions requesting that the FDA allow food manufacturers to count other non-digestible carbohydrates as fiber on the Nutrition Facts label. These included sugar cane fiber, apple fiber, and inulin, among others. We also issued a final guidance in March clarifying the information needed and the approach we planned to use to include additional non-digestible carbohydrates in our fiber definition. Petitioners were given the opportunity to revise their filings based on our more detailed guidance.

The decisions regarding most of the eight additional non-digestible carbohydrates come as a result of such petitions. But it’s important to note that these determinations are based on a careful review of the scientific evidence suggesting that each of these additional fibers has a beneficial physiological effect. The FDA also issued two denials to petitioners because we did not agree that the evidence submitted met the scientific standards, as described in our March scientific guidance. We’re also working expeditiously to complete our review and responses for the other petitions that we haven’t yet responded to.

The FDA is issuing new guidance today to express our intent to exercise enforcement discretion, permitting manufacturers to count these eight additional fibers in the dietary fiber declaration on the Nutrition Facts label pending completion of the agency’s rulemaking regarding adding additional fibers to the dietary fiber definition in FDA regulations.

Food manufacturers now have additional clarity to help them move forward to update their labels as needed ahead of the compliance date for the updated Nutrition Facts label, which is Jan. 1, 2020 for manufacturers with $10 million or more in annual food sales and Jan. 1, 2021 for smaller manufacturers. Our goal is to make sure that consumers can trust that the latest, tasty fiber-rich snack food or cereal that comes on the market can offer them some real health benefits.

We’re committed to ensuring that consumers have updated information so they can be empowered to make positive changes in their diets. Access to reliable, science-based information about food and diets not only helps consumers make healthier choices, but it also inspires food manufacturers to compete to offer products that have the healthy attributes that consumers seek and that food makers can declare on labelling. These efforts can help encourage food patterns that are consistent with the dietary guidelines, can help reduce chronic diseases, and can help ultimately alleviate health disparities through improved nutrition.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.